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Job Details

Regulatory Submissions Coordinator

Company: Medpace
Location: São Paulo
Reference: 2016-2154
Closing Date: 22 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Medpace is a global, full-service Clinical Research Organization (CRO) specializing in multiple therapeutic areas. Our headquarters are located in Cincinnati, Ohio, USA and we are active in over 45 countries across the globe. ...

Requirements:

Medpace is a global, full-service Clinical Research Organization (CRO) specializing in multiple therapeutic areas. Our headquarters are located in Cincinnati, Ohio, USA and we are active in over 45 countries across the globe. We continue to steadily grow and are looking to add to our team in Brazil!



As a Regulatory Submissions Coordinator (RSC) with Medpace Brazil you will have the opportunity to work with innovative therapeutic fields, with exposure to diverse, challenging studies ranging from phase I – IV. As a RSC you will report to the Regulatory Submission Manager and have the opportunity to use your expertise to guide and administer internal processes as well as advise clients on start-up activities. With continued growth, we are looking for proactive, positive and self-motivated individuals with a shared commitment to quality to join our supportive and dynamic team



DESCRIPTION OF JOB DUTIES
•Direct contact with sites during the study start up process;
•Prepare, review, and file clinical trial applications and marketing applications to ANVISA, CONEP and ethics committees;
•Ensure submissions comply with applicable regulations and guidance documents;
•Advise clients on changing regulations and compliance requirements;
•Track submissions and ensure timely filing of documents; and

•Managing Import licenses and import processes for studies.



•Proficiency in English;
•Bachelor’s degree in a science or health-related field;
•Proven experience of at least 2-3 years of regulatory submissions;
•Knowledge of ICH guidelines and applicable local regulations; and
•Excellent written and oral skills.



WHY MEDPACE?
At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.



WHAT TO EXPECT NEXT
We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.

Apply for this job: Regulatory Submissions Coordinator

Contact Information:

Address:  Medpace, Inc
5375 Medpace Way
Cincinnati
Ohio
45227
USA
Tel:  +1 513 579 9911
Fax:  +1 513 579 0444
Website:  Visit Our Web Site

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